K231272 is an FDA 510(k) clearance for the OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 1, 2023, 213 days after receiving the submission on May 2, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K231272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2023 |
| Decision Date | December 01, 2023 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |